Will the FDA approve any psychedelic substance for medical use before 2027?
Yes refers to: Any psychedelic substance for medical use
Short Answer
Both the model and the market expect Any psychedelic substance for medical use, with no compelling evidence of mispricing.
1. Executive Verdict
- Compass Pathways' COMP360 psilocybin delivered positive Phase 3 results.
- Trials demonstrated significant reductions in depressive symptoms for TRD.
- COMP360 holds Breakthrough Therapy Designation, suggesting expedited FDA review.
- Compass aims to file rolling NDA submission to FDA by late 2026.
- Planned commercial launch for COMP360 in USA by late 2026.
Who Wins and Why
| Outcome | Market | Model | Why |
|---|---|---|---|
| Any psychedelic substance for medical use | 28.0% | 30.5% | Research error: Internal Server Error |
Current Context
Psychedelic substance approval before 2027 faces mixed prospects, led by psilocybin. Compass Pathways announced positive Phase 3 results on February 17, 2026, for its synthetic psilocybin (COMP360) in treating treatment-resistant depression (TRD) [^]. The company plans to request a meeting with the FDA for a "rolling submission" of its New Drug Application (NDA) between October and December 2026, aiming for full submission by the end of 2026 [^]. If approved, COMP360 would be the first "classic" psychedelic cleared for the U.S. market [^]. The trial demonstrated a statistically significant reduction in depressive symptoms, with nearly 40% of participants on the highest dose showing a "clinically meaningful reduction" at six weeks [^]. The safety profile was "consistent" with earlier studies, showing no new or unexpected findings, including no clinically meaningful imbalance in suicidality, with common mild to moderate side effects such as headache, nausea, anxiety, and visual hallucination [^]. Separately, on February 17, 2026, Helus Pharma reported antidepressant potential for its DMT compound, SPL026, in a Phase IIa study for major depressive disorder (MDD), notable for its approximately 25-minute drug experience [^]. In contrast, the FDA issued a Complete Response Letter (CRL) in August 2024, declining approval for MDMA-assisted therapy for PTSD and requesting additional clinical trial data from Lykos Therapeutics [^]. This decision followed a negative FDA advisory committee vote in June 2024 due to concerns about study design and potential safety risks, significantly diminishing the likelihood of MDMA approval before 2027 [^]. The CRL was publicly released in September 2025, reflecting a shift towards increased FDA transparency [^].
Durability, abuse potential, and regulatory challenges are critical considerations for approval. While MDMA trials previously demonstrated "rapid, clinically meaningful, durable improvements" in PTSD symptoms and a favorable safety profile with transient increases in heart rate and blood pressure, jaw clenching, and mild nausea [^], the FDA is scrutinizing the durability of treatment response across all psychedelic candidates. Compass Pathways anticipates releasing 26-week data for COMP360 in Q3 2026, while concerns about MDMA's long-term benefits cited high dropout rates in follow-up studies [^]. Abuse potential is a crucial consideration for these Schedule I substances [^]. Expert opinions vary, with Compass CEO Kabir Nath seeing "blockbuster potential" for COMP360 and analysts confirming its results "met the Street's bar for success" [^]. While some officials, including Health Secretary Robert F. Kennedy Jr. and FDA head Dr. Marty Makary, express enthusiasm, other regulatory officials hold more conservative views, cautioning against rushing approvals [^]. Key concerns for the FDA include "functional unblinding" in trials, which impacted MDMA's review, and the regulation of drug-therapy combinations, as the FDA primarily approves drugs, not psychotherapy [^]. Broader issues include patient safety, long-term effects (e.g., cardiovascular risks, neurotoxicity, psychiatric adverse events), scalability, DEA rescheduling, and insurance coverage [^]. Upcoming events include AtaiBeckley's Phase III trial for mebufotenin benzoate nasal spray for TRD in Q2 2026 and the "Psychedelic Intersections 2026" conference in April 2026, which will discuss regulatory pathways [^].
2. Market Behavior & Price Dynamics
Historical Price (Probability)
Outcome probability
Date
This prediction market has exhibited a stable, sideways trading pattern since its inception, with the price largely confined to a narrow range between $0.26 and $0.35. The market opened at the top of this range at $0.35 and has since drifted slightly downward to its current price of $0.30. This price action indicates a consistent and sustained market sentiment that an FDA approval before 2027 is improbable. The $0.35 level has acted as a firm resistance, capping any initial optimism, while the $0.26 level has provided solid support, suggesting traders believe there is still a non-trivial, albeit small, chance of a "YES" resolution. The total volume of over 29,000 contracts indicates healthy liquidity and significant interest in the question.
The market's price behavior is best understood through the lens of the regulatory timeline. The positive Phase 3 trial results for Compass Pathways' psilocybin treatment in February 2026 did not trigger a significant price spike. This is because the market is focused on the company's stated plan to complete its New Drug Application submission by the end of 2026. A standard or even a priority FDA review period beginning at that time makes an approval before January 1, 2027, logistically difficult. The stable 30% probability suggests the market has fully priced in this timeline challenge, effectively concluding that while clinical results are promising, the administrative process is the primary obstacle. The lack of high-volume price swings around the news further confirms that market participants are not reacting to clinical efficacy but rather to the constraints of the calendar.
3. Market Data
Contract Snapshot
This market resolves YES if the FDA approves any psychedelic substance for medical use by the end of 2026. It resolves NO if the FDA has not approved any psychedelic substance for medical use by this date. The key deadline for approval is the end of 2026. No special settlement conditions are detailed in the provided content.
Available Contracts
Market options and current pricing
| Outcome bucket | Yes (price) | No (price) | Implied probability |
|---|---|---|---|
| Any psychedelic substance for medical use | $0.28 | $0.73 | 28% |
Market Discussion
Discussions surrounding the potential FDA approval of psychedelic substances for medical use before 2027 reveal cautious optimism, primarily driven by advancements in psilocybin research [^]. Compass Pathways' COMP360 for treatment-resistant depression has shown promising Phase 3 trial results and is targeting an FDA submission in late 2026 or early 2027, potentially leading to approval shortly thereafter [^]. However, the recent rejection of Lykos Therapeutics' MDMA for PTSD due to concerns over trial design, data integrity, and blinding challenges has introduced significant skepticism regarding the readiness of the medical system for psychedelics and underscores the unique regulatory hurdles these psychoactive compounds face [^]. Prediction markets currently reflect a moderate probability of at least one psychedelic substance gaining FDA approval before January 1, 2027 [^].
4. Why Did the Research for This Question Fail?
| Research Status | Failed (Internal Server Error) |
|---|---|
| Data Availability | None |
| Information Retrieved | 0 findings |
A technical server error prevented the research process completion. The research, which aimed to identify the earliest feasible New Drug Application (NDA) submission date for Compass Pathways' COMP360 and its potential PDUFA date based on historical FDA acceptance timelines for Breakthrough Therapy designated drugs with rolling submissions, encountered an internal server error. This technical issue directly prevented the successful execution of the research process.
No relevant data or findings are currently available. Consequently, no specific data points, key findings, or detailed summaries could be extracted from the research attempt. The inability to complete the research query means that no relevant information regarding COMP360's NDA or PDUFA timelines is available at this time.
5. What Was The Outcome Of The Research Request?
| Research Status | Failed due to an Internal Server Error |
|---|---|
| Data Retrieval | Unsuccessful |
| Information Availability | None |
The requested research on the FDA's PDAC composition encountered technical difficulties. The research task aimed to identify the likely composition of the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) that will review the COMP360 New Drug Application. Furthermore, it sought to ascertain specific, publicly stated concerns of potential panel members regarding unique challenges inherent in psychedelic trial design, such as functional unblinding and the effective implementation of psychological support protocols.
A technical issue prevented the extraction of specific findings. During the research attempt, the system encountered an Internal Server Error, which directly precluded the extraction or formatting of any specific findings or data points. As a result of this technical impediment, the research task could not be successfully completed, meaning there is no content available to summarize regarding the PDAC's composition or members' concerns on psychedelic trial design.
6. Why Was Research on This Question Unsuccessful?
| Research Status | Failed: Internal Server Error |
|---|---|
| Data Availability | None |
| Citations Found | Zero |
Server error hindered specific data extraction. The research process encountered an internal server error, which prevented the extraction of specific findings or data points related to the requested question.
Therefore, no relevant metrics could be analyzed. As a result, no specific metrics, values, or supporting textual information could be gathered or analyzed at this time.
7. Why Is Research Data Currently Unavailable?
| Research Status | Failed (Internal Server Error) |
|---|---|
| Data Availability | None |
| Information Extracted | No findings |
Specific findings could not be retrieved due to a technical error. The research process encountered an internal server error that prevented the retrieval of any specific findings or data for the requested query. This technical issue made it impossible for the system to access or generate the information required regarding the August 2024 Complete Response Letter (CRL) for Lykos Therapeutics' MDMA-assisted therapy.
No detailed information or insights are currently available. Consequently, no information could be processed or summarized concerning the specific data requirements outlined in the CRL, or any potential procedural pathways for Lykos to satisfy these requirements. Therefore, it is not possible to provide key data points, a summary of insights, or detailed context related to the query at this moment.
8. Why Was Research Data Unavailable Due to Internal Server Error?
| Research Outcome | Failed |
|---|---|
| Reason for Failure | Internal Server Error |
| Data Extracted | None |
An internal server error prevented the extraction of research findings. This technical issue meant that no specific data points, statistics, or detailed information related to the research query could be retrieved from the intended sources. As a direct consequence, the content for this section is entirely unavailable.
No analysis of COMP360 REMS requirements is currently possible. Due to the lack of successfully processed underlying research data, it is not feasible to provide a summary of key findings regarding COMP360's Risk Evaluation and Mitigation Strategy (REMS). Furthermore, critical deadlines, potential delays, or market impacts, such as those related to patient monitoring or setting-of-care restrictions, cannot be identified or outlined at this time. Further attempts would be necessary to resolve the server error and gather the required information.
9. What Could Change the Odds
Key Catalysts
Key bullish catalysts revolve around Compass Pathways' COMP360 psilocybin for Treatment-Resistant Depression (TRD). The company announced positive results from two pivotal Phase 3 trials in February 2026, demonstrating significant reductions in depressive symptoms [^]. Leveraging its Breakthrough Therapy Designation, Compass Pathways is in discussions with the FDA for a rolling submission and aims to file a New Drug Application (NDA) by the end of 2026, with intentions for commercial launch in the USA by late 2026, suggesting an expedited review [^]. Additionally, other substances such as LSD (MM120 for GAD), deuterated psilocybin analog (CYB003 for MDD), and luvesilocin (RE104 for Postpartum Depression) have received Breakthrough Therapy Designations, indicating a growing FDA recognition of psychedelics' therapeutic potential [^].
Conversely, a significant bearish catalyst was the FDA's rejection of Lykos Therapeutics' NDA for MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD) on August 9, 2024, via a Complete Response Letter (CRL) [^] . This denial followed a negative recommendation from an FDA advisory committee, citing concerns over trial design (e.g., unblinding and bias) and missing data [^]. This outcome significantly pushes back any potential MDMA approval beyond the 2027 deadline and signals heightened FDA scrutiny for all psychedelic therapies, potentially leading to more rigorous and longer review processes for other substances [^]. Unique challenges in trial design, such as blinding and integrating psychotherapy, as highlighted by FDA guidance, could further contribute to delays [^]. Moreover, even with FDA approval, subsequent U.S. Drug Enforcement Administration (DEA) rescheduling from Schedule I status, a process that can take up to 90 days, adds another hurdle to achieving medical use before 2027 [^].
Key Dates & Catalysts
- Expiration: January 08, 2027
- Closes: January 01, 2027
10. Decision-Flipping Events
- Trigger: Key bullish catalysts revolve around Compass Pathways' COMP360 psilocybin for Treatment-Resistant Depression (TRD).
- Trigger: The company announced positive results from two pivotal Phase 3 trials in February 2026, demonstrating significant reductions in depressive symptoms [^] .
- Trigger: Leveraging its Breakthrough Therapy Designation, Compass Pathways is in discussions with the FDA for a rolling submission and aims to file a New Drug Application (NDA) by the end of 2026, with intentions for commercial launch in the USA by late 2026, suggesting an expedited review [^] .
- Trigger: Additionally, other substances such as LSD (MM120 for GAD), deuterated psilocybin analog (CYB003 for MDD), and luvesilocin (RE104 for Postpartum Depression) have received Breakthrough Therapy Designations, indicating a growing FDA recognition of psychedelics' therapeutic potential [^] .
12. Historical Resolutions
No historical resolution data available for this series.
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